BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 9450667 · Received December 11, 2019

    Report

    Report Number
    8020045-2019-00032
    Event Type
    Injury
    Date Received
    December 11, 2019
    Report Date
    February 3, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    19005531000527
    PMA / PMN Number
    K024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF ALL CONCERNED LOT NUMBERS (190411-0349, 190516-0342, 190517-0344, 190625-0343, 190708-0342, 190927-0349 AND 191009-0347) HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE REPORTED INCIDENTS MAINLY AFFECT ELDERLY PATIENTS. THE IFU EXPLICITLY STATES: "TO PREVENT SKIN INJURIES, TAKE SPECIAL CARE WHEN REMOVING THE ELECTRODES FROM SENSITIVE SKIN (E.G., IN THE CASE OF ELDERLY PATIENTS, DIABETICS OR PATIENTS UNDER MEDICATION, SUCH AS STEROIDS, WHICH MAY HAVE A SKIN WEAKENING SIDE EFFECT)." IT IS UNCLEAR WHETHER THE USERS EXERCISED SPECIAL CARE UPON REMOVAL OF THE ELECTRODES. NO FURTHER CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 0

    ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT INCIDENTS WITH ECG ELECTRODES (MODEL FS-TF) AT (B)(6) IN UK. THE COMPLAINANT REPORTED "THIS IS (B)(6) REPORTING VARIOUS INCIDENTS OVER LAST FEW MONTHS WITH FSTF TEARING SKIN ON SOME PATIENTS." WE RECEIVED AN EXCEL SHEET SHOWING 31 CASES WHICH HAVE BEEN COLLECTED SINCE (B)(6). REVIEWING THIS LIST OF INCIDENTS WE NOTED THAT ONE CASE WAS LISTED TWICE. 25 REPORTED CASES RESULTED IN SKIN TEAR WITH POSSIBLE BLEEDING AND/OR BRUISING, 3 REPORTED CASES RESULTED IN ONLY BRUISING, 2 REPORTED CASES RESULTED IN NO INJURY. REQUESTING ADDIONAL INFORMATION ON THESE INITIAL CLAIMED INCIDENTS WE HAVE RECEIVED PARTIALLY FILLED IN QUESTIONAIRES TO 31 CASES. REVIEWING THESE INCIDENTS THE FOLLOWING MAIN INFORMATION WAS EXTRACTED: 17 OF THE 31 INCIDENTS HAVE BEEN TREATED AFTERWARDS TO PREVENT A PERMANENT INJURY OF THE PATIENT. IN 7 INCIDENTS, THE FOLLOW-UP TREATMENT WAS "NOT RECORDED" IN THE QUESTIONNAIRE AND IN THE REMAINING 7 INCIDENTS NO FOLLOW-UP TREATMENT WAS NECESSARY BECAUSE THERE WAS NO INJURY OF THE PATIENT SKIN. SUMMARIZING THE PROVIDED DATA OF THE 31 INCIDENTS, 10 PATIENTS WERE MALE AND THE REMAINING 21 WERE FEMALE PATIENTS. ALL PATIENTS, WITH EXCEPTION OF ONE 16 YEAR OLD PATIENT (NO TREATMENT WAS NECESSARY) ALL PATIENTS WERE OVER 59 YEARS OF AGE, 2 PATIENTS OVER 100 YEARS, 13 PATIENTS BETWEEN 90 AND 99 YEARS, 6 PATIENT BETWEEN 80 AND 89, AND 5 PATIENTS BETWEEN 70 AND 79 YEARS. FOR SOME PATIENTS THE SKIN WAS DESCRIBED "PAPER THIN SKIN NOTED", "FRAGILE SKIN" OR "DIABETES TYPE 2".

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF ONE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE INCIDENTS ARE REPORTED BECAUSE IT IS UNKNOWN IF AND HOW THE SKIN REACTION HAD TO BE TREATED. THE INCIDENT MIGHT NOT CONSTITUTE A REPORTABLE EVENT. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN TEARS CAN BE DRAWN SO FAR. WE HAVE REQUESTED FURTHER INFORMATION AND WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT.

    Description of Event or Problem · 1

    ON NOVEMBER 19TH, 2019, WE HAVE BEEN INFORMED ABOUT INCIDENTS WITH ECG ELECTRODES (MODEL FS-TF) AT YORKSHIRE AMBULANCES IN (B)(6). THE COMPLAINANT REPORTED "THIS IS (B)(6) REPORTING VARIOUS INCIDENTS OVER LAST FEW MONTHS WITH FSTF TEARING SKIN ON SOME PATIENTS." WE RECEIVED AN EXCEL SHEET SHOWING 31 CASES WHICH HAVE BEEN COLLECTED SINCE (B)(6) TILL (B)(6). REVIEWING THIS LIST OF INCIDENTS WE NOTED THAT ONE CASE WAS LISTED TWICE. 25 REPORTED CASES RESULTED IN SKIN TEAR WITH POSSIBLE BLEEDING AND/OR BRUISING. 3 REPORTED CASES RESULTED IN ONLY BRUISING. 2 REPORTED CASES RESULTED IN NO INJURY. ONLY FOR ONE CASE AN INVOLVED LOT NUMBER WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENTS, THE SKIN PREPARATION, THE DURATION OF WEARING, IF AND HOW THE SKIN INJURIES HAD TO BE TREATED AND THE CONCERNED LOT NUMBERS FOR THE REMAINING 29 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248684 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH FS-TF/6 190625-0343 19005531000527

    Patients

    Seq Age Sex Outcome Treatment
    1 Other